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OpenTrials
Completed

NCT Number: NCT00394875

The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes

To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Clinics

Zwolle, 8025 AB, Netherlands

About this study

Diabetes mellitus type 2 (DM2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 The worldwide prevalence of DM2 is high and is increasing steadily, also in The Netherlands.3-4 The burden of DM2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 In the treatment of DM2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 Therefore, the burden of treatment has increased and will further increase per patient as well as per population with DM2. In order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (NSD), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with DM2 who were referred by GPs to the diabetes outpatient clinics

Exclusion criteria

  • macroalbuminuria
  • serum creatinine level > 135 mol/l,
  • Cockcroft < 50 ml/min
  • alanine aminotransferase (ALT) > 120 U/l
  • pregnant woman

Treatment and study plan

Treated and educated by nurses specialized in diabetes.

Procedure

Primary outcomes

  1. mean decrease in:

  2. HbA1c

  3. blood pressure

  4. total cholesterol

  5. LDL cholesterol

  6. cholesterol/HDL-ratio

  7. proportion of patients achieving ranges of:

  8. glycaemic control

  9. lipid profile

Secondary outcomes

  1. health related quality of life (HRQOL)

  2. diabetes related symptoms

  3. patients' satisfaction

  4. health care consumption and costs

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Collaborators

  • Langerhans Foundation, the Netherlands
  • Netherlands: Ministry of Health, Welfare and Sports

Registry information

Official study title

The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes in a Secondary Care Setting: a Randomized Controlled Trial.

Important dates

Study start
2002
Study completion
2005
First posted
Nov 2, 2006
Registry last updated
Nov 2, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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